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Intercell AG

euro adhoc: Intercell AG
Quarterly or Semiannual Financial Statements / Intercell Announces Second Quarter 2005 Results

  Disclosure announcement transmitted by euro adhoc.
  The issuer is responsible for the content of this announcement.
12.08.2005
»EMEA Scientific Advice confirms Intercell’s development strategy for
Japanese Encephalitis Vaccine to be suitable for licensure in Europe
»Preparation of JEV Phase III clinical material on track. Start of
Phase III clinical trials planned for September »$ 6.6 million R&D
grant from US NIH for Intercell to develop biodefense vaccines
»Intercell coordinates the development of a novel vaccine against
lyme borreliosis - European Commission provides support of  EUR 1.4
million for the next two years »Revenues of EUR 4.1 million in the
first six month 2005. Net loss of EUR 8.1 million in first half of
2005 - up 14.9 % compared to first two quarters of 2004 - driven by
advancement of JEV vaccine development
Vienna (Austria), August 12, 2005 - Vaccine company Intercell AG
(VSE: ICLL) today announced its financial results for the second
quarter of 2005.  Intercell's aggregate revenues in the first six
months of 2005 were EUR 4.1 million, compared to EUR 4.0 million in
the same period in 2004. The revenues from collaborations and
licensing were EUR 3.5 million in the first half of 2005 and EUR 3.4
million in the first six months of 2004. Revenues from public
subsidiaries were EUR 0.6 million in both the actual and the
comparative period. However, revenues have been distributed very
unequally over the first two quarters of 2005 and 2004 and we expect
to continue to experience fluctuations in our quarterly revenue
figures. The company's net loss in the second quarter of 2005
increased by 29.4 percent to EUR 3.1 million compared to EUR 2.4
million in the second quarter of 2004. The net operating expenses
increased from EUR 6 million in the quarter ended June 30, 2004 to
EUR 7.1 million in the quarter ended June 30, 2005. The increase in
net operating expenses and net loss was primarily due to an increase
in research and development costs, which was partly offset by a
decrease in sales, general and administration costs and other
operating expenses, net. Intercell had EUR 66.0 million in liquid
reserves as of June 30th 2005, of which EUR 6.1 million was cash and
cash equivalents and EUR 59.9 million was available-for-cash
securities. Intercell intends to use its liquid reserves for the
further development and commercialization of the product candidates
and the further development of technologies.
Latest Achievement After the US FDA’s agreement on Intercell’s
development strategy last fall, the company has now received final
guidance for the Phase III development program from the Scientific
Advice Group of the European Medicines Agency (EMEA). Based on this
advice, Intercell will proceed with the global development program
also with a view to submitting a Marketing Authorization Application
(MAA) in Europe through the centralized procedure. Furthermore,
Intercell has also received approval for design and start of Phase
III clinical studies for the Japanese Encephalitis Vaccine (IC51)
from major European authorities. The Phase III clinical trial is now
approved in Australia, Austria, Bulgaria, Germany, Romania, the UK
and the US and is planned to start in September 2005.
Financial Highlights
EUR million         First two quarters ended         Year ended
                 June 31, 2005    June 31, 2004    Dec. 31, 2004
Revenues              4.1               4.0                 4.6
Net loss             (5.1)             (7.1)              (20.3)
Net operating
cash flow           (10.7)             (6.6)              (11.9)
Cash and marketable
securities, end of
period               66.0              41.8                31.3
Operational and Business Strategy Review Second Quarter 2005
Japanese Encephalitis (JEV) The highest priority is given to the
preparations for the start of Phase III trials in 2005, which include
the manufacturing of clinical consistency lots in our facility in
Livingston (Scotland).  Global, multi-center Phase III trials are
planned to start in September involving about 800 individuals to
demonstrate immunogenicity of the Intercell vaccine, compared to
mouse brain derived JE-VAX®, which is the only Japanese Encephalitis
vaccine approved in the US. At the same time, a series of additional
Phase III trials will be carried out to gather further immunogenicity
and safety data in approximately 4.000 subjects.
Hepatitis C The development of our therapeutic vaccine against
Hepatitis C continues to be fully on track. After completion of our
first Phase II clinical study in 2004, the clinical development
program has been further extended. A follow-up study has been
designed to further increase the T-cell response that is pivotal to
fight the infection by optimizing the route and the frequency of
vaccinations. The new study, for which recruitment has recently been
completed, is being performed at the General Hospital of Vienna,
where Intercell´s IC41 Hepatitis C vaccine is applied to more than 50
healthy volunteers by administering up to 16 vaccinations at weekly
intervals. Should results warrant it, the study will be extended to
chronic HCV patients in 2006. Intercells therapeutic Hepatitis C
vaccine is also being tested in combination with the
Interferon/Ribavirin standard therapy in another Phase II trial. This
trial is expected to be completed in 2006.
Research and Pre-clinical Products Significant progress has been made
in our research and pre-clinical programs: »Under a European Union
Sixth Framework project we have started research activities to
develop a novel vaccine against Lyme borreliosis, which is supported
by the European Commission with EUR 1.4 million over the next two
years. Intercell is the coordinator of this project, which brings
together expertise of leading scientists and biotech companies from
six institutions in Austria, the Czech Republic, Germany, and Sweden.
»Intercell has received an R&D grant from the National Institute of
Health (NIH) of the United States amounting to $ 6.6 million. The
grant supports the incorporation of Intercell’s proprietary adjuvant
program (IC31TM) into the development of biodefense vaccines. Within
Intercell's preclinical programs, the company primarily focuses on
vaccines against Streptococcus Pneumoniae and Group A Streptococcus
infections in order to define product candidates for future clinical
development. For the development of our novel antibody therapies we
intend to partner at least one program in 2005.
Strategic Alliances & Licensing All existing strategic alliances
which have resulted from Intercell's highly successful antigen
identification and adjuvant (IC31TM) technologies are moving forward
according to the intended timelines: »sanofi pasteur has exercised
its option on exclusive worldwide commercial rights on certain
bacterial vaccine antigens identified by Intercell's Antigen
Identification Program. Over the entire term of the agreement,
Intercell will be entitled to milestone based license payments
totaling to about EUR 23 million, as well as royalties on future net
sales.  »The joint project with the Statens Serum Institut for the
development of a new prophylactic tuberculosis vaccine has gained the
support of the Aeras Global TB Vaccine Foundation. Aeras will fund
the development of the vaccine and subsequent clinical trials and in
return will be given a sublicense for the future TB vaccine for a
number of developing countries. In some of our partnerships, first
clinical trials are expected within this year. Intercell's major
strategic partners are: Merck&Co., Inc. (US), sanofi pasteur
(France), Statens Serum Institut (Denmark) and SciGen Ltd.
(Australia/Singapore). We expect further alliances resulting from our
technology plattforms within the next months.
The full quarterly report including un-audited financial statements
can be downloaded at www.intercell.com
Conference Call regarding the report Q2 2005
Friday, August 12, 2005
14.00 CET
Tel: +43.1.23032
PIN: 618421 (special PIN for analysts on request)
This communication expressly or implicitly contains certain
forward-looking statements concerning Intercell AG and its business.
Such statements involve certain known and unknown risks,
uncertainties and other factors which could cause the actual results,
financial condition, performance or achievements of Intercell AG to
be materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements.
Intercell AG is providing this communication as of this date and does
not undertake to update any forward-looking statements contained
herein as a result of new information, future events or otherwise.
end of announcement                               euro adhoc 12.08.2005 07:32:45

Further inquiry note:

Intercell AG
Mag. Katharina Wieser
Head of Corporate Communications
Tel. +43 1 20620-303
kwieser@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN:
Börsen: Wiener Börse AG / official market

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